医疗技术评估是否会影响获得药品的机会?
Melanie Büssgen1, Tom Stargardt2
1Hamburg Center for Health Economics, University of Hamburg, Hamburg, Germany. melanie.buessgen@uni-hamburg.de.
概括
德国的医疗技术评估 (HTA) 条例减缓了制药推出延迟的减少,但改善了药物可用性. 政策制定者可以利用这一点来平衡成本节约和患者获取.
科学领域:
- 卫生经济学 卫生经济学
- 制药政策 制药政策
- 监管科学 监管科学
背景情况:
- 药品成本上升导致全球实施医疗技术评估 (HTA) 系统.
- 在药品市场准入方面,HTA通常被认为是"第四个障碍".
- 德国于2011年推出了HTA系统AMNOG,以管理药物成本和获取.
研究的目的:
- 评估基于HTA的监管对药品获取的因果关系.
- 评估德国AMNOG系统对药物推出延迟和可用性的影响.
- 为决策者提供信息,以平衡成本效益和患者获得药物的机会.
主要方法:
- 利用了来自30个欧洲国家的制药推出数据 (IQVIA数据库).
- 采用差异差异 (DiD) 模型来分析AMNOG的影响.
- 比较德国与比较国家 (奥地利,捷克,意大利,葡萄牙,英国) 的推出延迟和可用性.
主要成果:
- 在AMNOG实施后,六个国家的总体发射延迟减少.
- 与比较国家相比,德国的AMNOG引入导致推出延迟的减少较小 (+4.31个月,p=0.05).
- 在AMNOG实施后,德国的药品供应量显著增加 (+5.78%,p=0.009).
结论:
- 基于HTA的监管,就像德国的AMNOG一样,在监管节省成本的目标和及时患者获得药品之间进行了权衡.
- 调查结果表明,虽然AMNOG影响了推出动态,但它也提高了药物的可用性.
- 证据支持知情政策制定,以优化制药成本控制和获取之间的平衡.
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